A Single Arm, Open-label, Phase IIb Study to Assess the Efficacy and Safety of the Combination of Cediranib and Olaparib Tablets in Women With Recurrent Platinum Resistant Epithelial Ovarian Cancer, Including Fallopian Tube and/or Primary Peritoneal Cancer Who do Not Carry a Deleterious or Suspected Deleterious Germline BRCA Mutation

Trial ID # NCT02889900; CONCERTO
Phase II
Drug Class DNA Damage Repair Pathway Inhibitors: PARP
Drug Name Olaparib
Alternate Drug Names AZD2281, Lynparza
Drugs in Trial Cediranib, Olaparib
Eligible Participant

Platinum resistant ovarian cancer with at least 3 prior therapies

Patients Enrolled

60 non-gBRCA MUT or unk; median 4 prior therapies (3-10)

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DCR, DoR, PFS, OS, evaluated per RECIST

Efficacy

ORR: 15.6% (1CR, 8PR, n=59)
DCR: 23.7%
DoR: 8.3 months
PFS: 5.1 months
OS: 13.2 months

Clinically Significant Adverse Events

Serious AE:
Grade 3-4 AE:

Conclusion

Olaparib+cediranib has manageable toxicity and shows evidence of anti-tumor activity in heavily pretreated platinum resistant non-gBRCA MUT patients

Reference

Lee J-m et al. Cediranib in combination with olaparib in patients without a germline BRCA1/2 mutation with recurrent platinum-resistant ovarian cancer: Phase IIb CONCERTO trial. J Clin Oncol (2020) 38: (suppl; abstr 6056)
https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.6056

Lee J-m et al. Poster
https://www.clearityfoundation.org/wp-content/uploads/2020/06/OlaCed-CONCERTO-ASCO-2020.jpg

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